Conventionally, cancer diagnosis methods, such as serological diagnosis that examines tumor markers in serum, as well as tissue diagnosis and cytological diagnosis using biopsy, have been publicly known. When, however, these methods are used in diagnosing cancers, the results from examinations may be obtained only at lower reliabilities or a variation inevitably occurs in diagnoses between diagnosticians and between medical institutions. Against this background, recently, molecular diagnosis based on proteins expressing in vivo has attracted much attention as one of methods for uniform cancer diagnosis with less variation in diagnosis between diagnosticians.
For example, a patent document PCT No. WO99/42821 proposes a diagnosis method that uses the expression levels of CDK1 and CDK4 of the sample, as well as P53 mutation level thereof, if necessary, as indexes. Another patent document U.S. Pat. No. 6,709,832B1 proposes a method for diagnosing cancer or precancerous condition based on an index of over-expression levels of CDK4, CDK6, and cyclin-dependent kinase inhibitor (CDK inhibitor). Further another patent document U.S. No. 2002/164673A1 proposes a method for measuring CDK activity values using fluorescence and a method for diagnosing cancers based on the values from the measurements thereof.
For example, a patent document PCT No. WO99/42821 discloses a method for predicting the effectiveness of an anticancer drug therapy, one of cancer therapy methods, involving; a step of identifying an anticancer drug biocompatibility marker gene based on the sensitivity of a cultured cancer cells line to the anticancer drug and a gene expression profile of the cells in its intact condition; and a step of predicting the biocompatibility of the anticancer drug with the identified anticancer drug biocompatibility marker gene and unknown specimens using the gene itself.
PCT No. WO99/42821, U.S. Pat. No. 6,709,832B1, and U.S. No. 2002/164673A1 disclose a method for determining whether test specimens have cancerated or proceeded into a precancerous condition, while they describe no method for determining malignancy grades of cancers, that is, for determining prognosis.
In addition, U.S. No. 2002/164673A1 discloses method for predicting the effectiveness of an anticancer drug therapy, though the results are obtained only at a lower accuracy when this method is used to predict the effectiveness of an anticancer drug therapy.